Table 5.
Summary of adverse events
| Category | Number of events | Number of subjects | % of subjects (N = 65) |
|---|---|---|---|
| Total adverse events (AEs) | 37 | 17 | 26.2% |
| AEs related to treatment | 2 | 2 | 3.1% |
| - Injection site swelling | 1 | 1 | 1.5% |
| - Injection site pain | 1 | 1 | 1.5% |
| Serious adverse events (SAEs) | 3 | 3 | 4.6% |
| - Related to treatment | 0 | 0 | 0% |
| Withdrawals due to AE | 2 | 2 | 3.1% |
| Deaths | 0 | 0 | 0% |
Adverse events (AEs) were coded using MedDRA version 25.1 and analyzed in the safety population (N = 65). Three serious adverse events (SAEs) were reported, two of which led to study discontinuation. None of the SAEs were considered related to the study treatment. All treatment-related AEs were mild in severity